Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
Farr Institute of Health Informatics, University College London.
Catheter Cardiovasc Interv. 2019 Jul 1;94(1):61-69. doi: 10.1002/ccd.28041. Epub 2019 Jan 2.
Polymer-free amphilimus-eluting stents (PF-AES) represent a novel elution-technology in coronary stenting. We aimed to assess 1-year clinical outcomes of PF-AES as compared to latest-generation permanent polymer zotarolimus-eluting stents (PP-ZES) in a real-world all-comers setting.
A prospective registry of patients treated with either PF-AES or PP-ZES between 2014 and 2016 was conducted. The primary outcome was defined as major adverse cardiac and cerebrovascular events (MACCE), and the secondary outcome was defined as target-lesion failure (TLF) at 1 year. To account for measured confounders, a propensity-score adjusted Cox proportional-hazard model was built to evaluate clinical outcomes.
A total of 734 consecutive patients with 1,269 DES implantations were enrolled. The population was characterized by 28% diabetes, 24% ST-segment elevation myocardial infarction, and a high number of complex lesions (69%). The rate of MACCE was 11.5% for PF-AES and 13.6% for PP-ZES, p = 0.11. TLF was numerically lower in PF-AES as compared to PP-ZES (5.4 vs. 6.1%, p = 0.68). After propensity-score adjustment, PF-AES showed a trend toward a lower rate of MACCE and a favorable rate of TLF as compared to PP-ZES (HR 0.70; 95%CI 0.45 to 1.10, P = 0.12; and HR 0.88; 95%CI 0.47 to 1.65, P = 0.68, respectively). Rates of definite ST were low (0.8 vs. 0.3%, p = 0.62).
Our study suggests that implantation of PF-AES was safe and effective in real-world patients, with low-rates of MACCE and TLF at 1 year. Our data needs to be confirmed by a large trial to evaluate the clinical outcomes of this novel polymer-free, eluting-technology used in PF-AES.
聚合物自由的 Amphilimus 洗脱支架（PF-AES）代表了冠状动脉支架的一种新洗脱技术。我们旨在评估在真实世界的所有患者中，与最新一代永久性聚合物佐他莫司洗脱支架（PP-ZES）相比，PF-AES 的 1 年临床结果。
对 2014 年至 2016 年期间接受 PF-AES 或 PP-ZES 治疗的患者进行前瞻性登记。主要结局定义为主要不良心脏和脑血管事件（MACCE），次要结局定义为 1 年时的靶病变失败（TLF）。为了考虑到测量的混杂因素，建立了倾向评分调整的 Cox 比例风险模型来评估临床结果。
共纳入 734 例连续患者，共植入 1269 个 DES。该人群的特点为 28%的糖尿病、24%的 ST 段抬高型心肌梗死和大量复杂病变（69%）。PF-AES 的 MACCE 发生率为 11.5%，PP-ZES 的 MACCE 发生率为 13.6%，p 值为 0.11。PF-AES 的 TLF 数值低于 PP-ZES（5.4%比 6.1%，p = 0.68）。在进行倾向评分调整后，与 PP-ZES 相比，PF-AES 的 MACCE 发生率和 TLF 发生率呈下降趋势（HR 0.70；95%CI 0.45 至 1.10，P = 0.12；和 HR 0.88；95%CI 0.47 至 1.65，P = 0.68，分别）。明确的支架血栓形成发生率较低（0.8%比 0.3%，p = 0.62）。
我们的研究表明，在真实世界的患者中，PF-AES 植入是安全有效的，1 年时的 MACCE 和 TLF 发生率较低。我们的数据需要通过一项大型试验来证实，以评估这种新型无聚合物、洗脱技术在 PF-AES 中的临床效果。
